510(k) K242857
K242857 is an FDA 510(k) premarket notification submitted by Finemedix Co., Ltd. for the device "ClearHemograsper". The FDA issued a decision of Substantially Equivalent on May 21, 2025. The device falls under product code KGE (Forceps, Biopsy, Electric), a Class II device regulated under 21 CFR 876.4300. Finemedix Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 21, 2025
- Date Received
- September 20, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Forceps, Biopsy, Electric
- Device Class
- Class II
- Regulation Number
- 876.4300
- Review Panel
- GU
- Submission Type